Rituximab

Chemical formula: C6416H9874N1688O1987S44 

Therapeutic indications

Rituximab is indicated for:

Monotherapy in stage III-IV follicular non-Hodgkin's lymphoma

Population group: only adults (18 years old or older)

Truxima monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Diffuse large B cell non-Hodgkin's lymphoma, CD20 positive

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

Rituximab is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.

Rituximab in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥6 months to <18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Chronic lymphocytic leukaemia

Population group: only adults (18 years old or older)

Rituximab in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Rheumatoid arthritis

Population group: only adults (18 years old or older)

Rituximab in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic medicinal product (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.

Rituximab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Granulomatosis with polyangiitis and microscopic polyangiitis

Population group: only adults (18 years old or older)

Rituximab, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).

Rituximab, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥2 to <18 years old) with severe, active GPA (Wegener’s) and MPA.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Rituximab is contraindicated in the following cases:

Active, severe infections

Infectious disease

Severely immunocompromised state

Immunodeficiency

Severe heart failure or severe, uncontrolled cardiac disease

at least one of
Heart failure New York Heart Assosiation Class IV
Heart disease

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Factors such as age, gender, and health history are evaluated to create a personalized medication regimen.

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